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Senior Analytical Scientist Life Cycle @ Pfizer

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 Senior Analytical Scientist Life Cycle

Job Description

Job Title: Senior Analytical Scientist Life Cycle Management

Job Category: Research

Short Description: This role is responsible for review and executing Parenteral Drug Product activities at the Synergy Site in Chennai, in compliance with highly regulated GMP standards. The incumbent will perform qualitative and quantitative analyses of organic and inorganic compounds, as well as biologics, to determine their chemical and physical properties during chemical syntheses and drug product development processes. They will also be responsible for validating analytical methods and transferring them to manufacturing sites.

Key Responsibilities:

- Collect literature from available sources and compile.

- Prepare analytical requirements and perform analytical method development for new projects.

- Execute error-free analysis, review data in line with applicable site procedures, and deliver on-time results.

- Preparation of method development reports and handover of appropriate documents to the respective project team.

- Participate in project and technical discussions/presentations.

- Ensure the maintenance of equipment, columns, standards, and samples.

- Maintain files and registers with respect to compliance.

- Ensure the destruction of analyzed samples.

- Monitor Empower data, eLN system, and Audit trail periodically for any deviations.

- Ensure the compliance of the lab in line with applicable site procedures.

- Maintain training status above 95% in PLA training system and adhere to safety guidelines.

- Provide weekly updates and/or monthly reporting of key activities.

- Provide on-the-job training and qualification for newly joined scientists.

- Provide review comments on new (or) revised procedures.

- Create change requests and action items on Commissioning/Decommissioning of equipment/instruments.

- Provide support on investigation as a PHP practitioner.

Expectations:

- Advanced knowledge of varied aspects or a specialized aspect of a discipline and working knowledge of principles and concepts in other relevant disciplines.

- Technical and functional knowledge to design experiments and independently complete work within own workgroup/project team, working on multiple subprojects in parallel.

- Acts as a technical and scientific resource within own project team/discipline.

- Recognized as a technical expert and competent scientific contributor.

- Frequently develops and may create novel processes and hypotheses using new ideas and knowledge.

- Makes decisions that require developing new options to solve moderately complex problems.

- Works in ambiguous situations within own project team. Moderate uncertainty of successful scientific outcome for some of the solutions attempted.

- Decisions consistently impact the whole project team.

- Uses own scientific judgment to apply and adapt standard methods and techniques with increased independence by applying prior work experience.

- Works independently on assignments using knowledge and work experience.

- Proactively gathers input from colleagues to assist with novel (to them) aspects of the job.

- Identifies and develops scientific activities/projects to support short-term operational goals.

- Provides formal/informal mentoring within the project team.

Qualifications:

M. Sc. Chemistry/ Analytical/ M. Pharm. (Pharmaceutical analysis)/ Ph. D with 10 to 15 years of experience in Pharmaceutical Industry

Physical/Mental Requirements:

  • Preferably good in numerical ability
  • Standing to conduct experiments, observing and online documenting
  • Able to work in an oncology lab with all necessary PPEs

Non-Standard Work Schedule, Travel or Environment Requirements:

  • Occasionally to work on shifts
  • No objection with PPEs while working in an oncology lab.



Research and Development

#LI-PFE

Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area: Pharmaceutical & Life Sciences
Role Category: Pharmaceutical & Biotechnology
Role: Formulation Scientist
Employement Type: Full time

Contact Details:

Company: Pfizer
Location(s): Chennai

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Keyskills:   PLA Onology Compliane Analytial PHP Management GMP Operations Researh Auditing

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₹ -41 Lacs P.A

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